Hologic gains FDA approval for newly-acquired genotype assay; St. Jude Medical deals with multiple downgrades;

 @FierceMedDev: Michael Mahoney, Boston Scientific's new CEO, inherits a giant in transition on day one. More | Follow @FierceMedDev

 @MarkHFierce: Advanced Cell Diagnostics pulled in $12 million in new Series B financing. More | Follow @MarkHFierce

 @DamianFierce: It's campaign season, and medical device companies are donating big. Find out how and to whom in our report. More | Follow @DamianFierce

> Hologic's ($HOLX) Gen-Probe division got FDA approval for its Aptima HPV genotype assay, using RNA markers to detect the virus. News

> With 510(k) clearance in hand, Teleflex ($TFX) is launching the Arrow FlexBlock, a continuous nerve peripheral nerve block catheter. More

> Adding to its list of woes this year, St. Jude Medical ($STJ) has been hit with 5 back-to-back downgrades from equity analysts. Story

> Danaher Corporation ($DHR) has completed its $338 million acquisition of diagnostics company Iris International. Item (reg. req.)

> Italian medical device maker the Sorin Group said earthquakes slashed profits nearly 100% during its third quarter. Story

> NeuroMetrix sealed a distribution deal with OneSource Medical Group for its Sensus pain management device. Item

> Ireland's HiberGene Diagnostics has named Tony Hill it new CEO. Hill was previously a vice president at OraSure Technologies. Article

Biotech News

 @FierceBiotech: Trending on FierceBiotech.com : The 2012 Biotech Graveyard. Special Report | Follow @FierceBiotech

 @JohnCFierce: Medivir would like everyone to know that JNJ's hep C drug came from them. Alios outlicensed Vertex drug, but they've always been low profile. | Follow @JohnCFierce

 @RyanMFierce: Sanofi deal bolsters Medidata in record quarter for revenue, boosts number of cloud customers in pharma. More | Follow @RyanMFierce

> Hurricane Sandy flooding wipes out years of drug research at NYU lab. Story

> Vertex partners with J&J, GlaxoSmithKline on new hep C combos. News

> FDA spurns new low-sodium drug from Cornerstone. Article

Pharma News

@FiercePharma: Spectrum rejigs sales ops after Allos buyout, to tout its 3-drug stable. Prep for new ones, too. More | Follow @FiercePharma

> Pfizer discloses $491M charge for Rapamune marketing settlement. Article

> Switzerland, Canada clear Novartis flu vaccines after tests. News

Vaccines News

 @AlisonBFierce: In search of a lasting flu vaccine: Researchers work to find decades of protection with one shot. More | Follow @AlisonBFierce

> Health officials clash over whether to scrap malaria program. Item

> Mumps vaccine succumbs to face-to-face contact. Story

> U.K.'s HPA lands $6.4M for anthrax vaccine research. Article

> Study: Flu vaccine protects against heart attacks. More

Pharma Manufacturing News

> Lonza whacking 500 jobs, 400 at Swiss API plant. Story

> Compounder recall may make drug shortages more severe. News

> Novartis adding $500M biologics plant in Singapore. Report

> Boston-area pharma plant goes up for auction to pay debts. More

Suggested Articles

The immunoassay will measure neurofilament light chain protein levels, found in the blood and cerebrospinal fluid, and linked to nerve damage.

Emmecell aims to make corneal transplant surgery, which can take up to a year to heal from and fails up to 20% of the time, a relic of the past.

Seven developers will provide digital health solutions aimed at the COVID-19 pandemic, including smartphone apps, wearables and big data programs.